Interested In Combination OTC/Dietary Supplement Products?

Here’s what you should know.

By Todd Harrison

Have you ever thought of marketing a combination OTC monograph drug/dietary supplement product? Some companies already have. Is it legal? Maybe, especially in light of FDA’s decision to permit certain structure/function claims for dietary supplements that were previously reserved to OTC drug products. Before we launch into the specifics, there is some information you should know about OTC drug monograph system.

FDA’s OTC drug monograph system sets out the active ingredients and identifies other requirements for marketing certain OTC drug products in the U.S. without the need for prior approval from FDA to market the product. Pursuant to 21 C.F.R. § 330.1(e), the OTC monograph system permits an OTC drug product to contain any suitable inactive ingredient unless specifically prohibited by FDA in the particular monograph. In essence, this means that an inactive ingredient:

(1) must be safe to use in combination with the active ingredient, and
(2) must not interfere with the active drug ingredient, i.e., diminish or en­hance the effectiveness of the active ingredient.

Thus, vitamins, minerals and herbs may arguably be added to the OTC monograph drug product as long as they do not affect the safety or effectiveness of the active drug ingredient, even though those ingredients may impart their own beneficial qualities to the overall product. Hence, there is a reasonable argument that the FD&C Act and FDA’s OTC drug regulations permit the addition of “dietary ingredients,” as long as therapeutic claims (i.e, “drug” claims) are not made for the dietary ingredients, the product is manufactured in an FDA-registered drug establishment and is listed with FDA and current good manufacturing practices (CGMP’s) for drugs are used in the manufacturing of the product. Indeed, at least two products are presently being marketed as combination OTC drug/dietary supplement products.

Psyllium Husk OTC Products

Psyllium husk has a long history of being sold as an OTC drug product for the natural relief of constipation. Its active ingredient, psyllium husk, is a natural bulk forming laxative that may be marketed under the OTC drug monograph for laxative products. Psyllium husk also has a long history of food use, including dietary supplement use. After FDA approved a health claim petition for psyllium husk and coronary heart disease (CHD), at least one manufacturer relabeled and repositioned its OTC drug product as an OTC bulk laxative drug/dietary supplement product. This repositioning did not pose a significant regulatory risk to the product because psyllium husk could be marketed as either an OTC active drug ingredient or a dietary supplement with similar claims. For example, psyllium husk that is marketed pursuant to the OTC laxative monograph could make the claim “helps relieve constipation,” while a psyllium husk supplement can make the claim “helps promote bowel regularity” or “helps alleviate occasional constipation.” The OTC drug product label, however, could not utilize the FDA-approved psyllium husk/CHD health claim or the structure/function claim “helps promote a healthy heart.”

To remedy this problem and to take advantage of the psyllium husk/CHD health claim, a split label is used for the product. One side of the label promotes the product’s OTC drug laxative use and conforms with FDA’s OTC drug monograph for laxatives, while the other side of the label conforms with FDA’s labeling regulations for dietary supplements and the requirements of the psyllium husk/CHD health claim regulation. Moreover, the label clearly indicates which side to read for use as a drug and which side to read for use as a dietary supplement.

Weight Loss Products

At least one company is marketing a combination OTC drug/dietary supplement weight control product with an active OTC drug ingredient, PPA, and various dietary ingredients. However, the claims that are being made for the combination product are arguably permissible claims for an OTC weight control drug product as well as a di­etary supplement.

Dietary supplements are products that contain dietary ingredients that are intended to supplement the human diet through ingestion (FD&C Act § 201(ff)(1)). Dietary supplements differ from drugs in that they are not intended to diagnose, cure, treat, mitigate or prevent disease (FD&C Act § 201(g) (definition of a “drug”)). While the label and labeling of a dietary supplement may bear structure/function claims, they may not contain express or implied disease claims (FD&C Act § 403(r)(6)). FDA indicated in its final rules regarding structure/function claims that claims regarding “weight loss” are permitted as long as the claims did not cross over into obesity treatment claims.

This product also uses a split label approach. One side of the label conforms with the proposed monograph set out in FDA’s advance notice of proposed rulemaking (ANPR) for OTC weight loss drug products (47 Fed. Reg. 8466 (February 26, 1982)), while the other side bears labeling as a dietary supplement. Moreover, the dietary ingredients present in the product are used in other weight management dietary supplements and are all “old” dietary ingredients that have a history of safe use in dietary supplements. It would also seem unlikely that the dietary ingredients in the product would interfere with PPA’s mode of action. Because the product’s dietary ingredients would appear to be suitable inactive drug ingredients and the claims being made on the product’s label are permitted struc­ture/function claims for dietary supplements, as well as permitted OTC drug weight loss claims, it is unlikely that FDA would take regulatory action against this combination product.

Conclusion

While a reasonable argument exists that the FD&C Act does not prohibit marketing OTC drug/dietary supplement combination products, FDA may disagree. Indeed, this approach may only present a low regulatory risk when the OTC drug/dietary supplement product is either a product that contains the same active drug and dietary ingredient(s) or the claims for the OTC drug product and the dietary supplement product are permitted for both products. In the latter situation, FDA’s decision to permit a wide variety of claims for dietary supplements, such as “helps alleviate occasional nausea,” “helps alleviate minor aches and pains,” “helps alleviate occasional gas,” that were previously reserved to OTC drug products, may offer the enterprising supplement company an opportunity to enhance its product line. If a company wishes to explore this option, it will need to take into account the following factors:

• A split label must be used, with one part of the label providing the required OTC labeling and the other part providing the necessary dietary supplement labeling;
• CGMP’s for drugs must be followed;
• The product would be subject to FDA’s drug establishment registration and drug listing requirements;
• In the case where the dietary ingredient(s) and active drug ingredient(s) are different, the dietary ingredient(s) must be safe and suitable inactive drug ingredient(s); and
• FDA may disagree with the company’s decision to market a combination product.

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